In-home Obesity Prevention to Reach Low-income Infants



Status:Enrolling by invitation
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:4/6/2019
Start Date:November 1, 2018
End Date:May 31, 2022

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In-home Obesity Prevention to Reach Low-income Infants Through Maternal and Social Transmission

Existing obesity prevention efforts have had limited success among underserved, low-income
children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation
Program (HVP), which serves at-risk, low-income, ethnically/racially diverse mothers and
their infants, to test the effectiveness of delivering obesity prevention as part of their
weekly, in-home services. The study will evaluate whether the integration of an obesity
prevention enhancement module into existing HVP services, reduces the risk and incidence of
obesity and associated risk factors in mothers and infants, compared to the provision of
standard home visitation services. The study also focuses on the role of maternal factors
(maternal diet, physical activity, food insecurity and feeding practices) and social factors
(social network support) as mechanisms operating on infant outcomes.

More than 40% of children enrolled in federally funded programs are overweight or obese by
age 5. Unfortunately, extant obesity efforts have had a limited impact among low-income
underserved children, in part because of limitations inherent to existing programs: 1) short
duration and low intensity; 2) late timing of implementation, when children are already
overweight or obese; 3) delivery methods limiting their accessibility and sustainability; and
4) failure to address barriers such as a lack of culturally competent services, poverty,
housing instability, and access to care, which interfere with healthy lifestyle changes. To
address these gaps, we have integrated simple, evidence-based nutrition and physical activity
components as part of the services already delivered by our home visitation partner, Healthy
Families America, with the long-term goal to deploy these efforts to Home Visitation Programs
(HVPs) nationwide. Annually, over 500 publicly and privately funded HVPs provide nationwide
services to more than 650,000 low-income, underserved infants and their families. The home
visiting structure is not only an unparalleled model for scalable and sustainable childhood
obesity prevention, but it also provides a unique opportunity to understand factors related
to the intergenerational transmission of obesity in families who are most at risk.

Over the last four years, our transdisciplinary team of researchers, home visiting
stakeholders, families, and community stakeholders has integrated evidence-based nutrition
and physical activity components into an engaging obesity prevention curriculum delivered in
English and Spanish as an enhancement module to the services of our HVP partner. Our pilot
work supports the successful integration, feasibility, and preliminary efficacy of
integrating obesity prevention as part of HVP services. The proposed study tests the
large-scale and sustained impact of home-based obesity prevention on infant's and mothers'
obesity outcomes, and studies key mechanisms of maternal and social transmission on infants'
obesity risk.

Specifically, 300 low-income mothers/infants enrolled in Healthy Families America's HVP will
be recruited and enrolled in the study. Based on standard HVP procedures, mothers/infants
will be matched to highly trained home visitors based on their ethnicity/race and language
preferences. Home visitors, in turn, will be randomly assigned to deliver the standard HVP
curriculum only or the standard HVP curriculum + obesity prevention as part of their weekly
home visits, for the first 18 months of HVP services. Comprehensive assessments of
mothers/infants will be conducted at enrollment and after 6 and 18 months of intervention.

Aim 1 (maternal and infant outcomes). Test the direct effects of obesity prevention on
infants and mothers' weight, metabolic risks, diet/energy intake, and physical activity. This
will be accomplished by comparing changes in body weight, metabolic markers, and eating and
activity-related behaviors between infants/mothers across study arms (HVP only vs.
HVP+obesity prevention). These results will indicate whether HVP is an effective
infrastructure for primary and secondary obesity prevention.

Aim 2 (maternal transmission). Test whether breastfeeding and maternal diet and activity,
feeding practices, and food insecurity mediate the effect of obesity prevention on infants'
outcomes. This aim will test mechanisms of maternal transmission on infants' obesity risks.

Aim 3 (social transmission). Aim 3 is two-pronged. Aim 3a tests the direct effect of
HVP+obesity prevention (vs. HVP only) on the characteristics of the social and community
networks that surround mothers and infants (i.e., the density, composition, and quality of
health support networks). Aim 3b tests whether the characteristics of social networks mediate
the effects of obesity prevention on maternal and infant outcomes. These findings will
indicate if the delivery of in-home obesity prevention efforts can alter and/or activate
social network mechanisms.

Secondary Aim. Conduct a real-life economic analysis (costs, cost-savings, and non-monetary
benefits) of integrating obesity prevention into existing HVPs.

This proposal addresses the impetus to develop interventions targeting at-risk infants before
obesity is established. Although maternal-infant interventions are much-needed, they present
implementation and dissemination challenges, including limitations on compliance and
retention, and limited potential for scalability and sustainability. Our proposed strategy
overcomes these challenges through an innovative solution that merges evidence-based
nutrition and activity components into an existing, ongoing federally-funded infrastructure.
The proposed research is timely as the Institute of Medicine, the United States Department of
Agriculture, and Health and Human Services (DHHS) extend their recommendations to address key
factors influencing obesity risk in children from birth to 24 months of age.

*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet
inclusion criteria to participate.

Inclusion Criteria:

Mothers:

- Enrolled in a partnered home visitation program

- Mother or primary caregiver of 2-8 month old child

- BMI above 18.5

- Generally Healthy

Children:

- 2-8 months of age at time of enrollment

- Parent or primary caregiver receiving home visitation services

Exclusion Criteria:

Mothers:

- Any history of an eating or feeding disorder, or obesity related syndrome (such as
Prader-Willi)

- Diagnosis of Schizophrenia

- Currently enrolled in a diet and weight loss program, AND either a) significant weight
loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current
diet and weight loss program.

Infants:

- Infant is clinically underweight (<5th percentile) or has a history of a feeding or
eating disorder
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